Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Perceived voice effort
研究概览
简要总结
The general aim of the study was to provide evidence for the usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (laryngeal dystonia). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options.
详细描述
Participants with either adductor or abductor-type of spasmodic dysphonia applied VTS at home for a period of 2 months. During the first four weeks they gradually increased their weekly dosage from 3 to 6 days per week. Each application per day lasted 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
- •Diagnosis is made by a voice disorder specialist.
排除标准
- •Regular intake of benzodiazepines
- •Cognitive impairment: score < 27 on Mini-mental state examination
- •Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis
研究组 & 干预措施
Intervention
Laryngeal vibro-tactile stimulation
干预措施: Vibro-tactile stimulation (Device)
结局指标
主要结局
Perceived voice effort
时间窗: 8 weeks
Participants will rate their perceived effort level of vocalization on an ordinal scale of 0 to 10 (0 being with no effort and 10 being with maximal effort). The recordings will provide subjective impression of treatment.
次要结局
- The duration of voice break(8 weeks)
- The number of voice breaks(8 weeks)
- Adherence Rate (Feasibility)(Week 1-4)
研究者
Juergen Konczak
Professor; Director Human Sensorimotor Control Laboratory
University of Minnesota